Clinical trial · Interventional
Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer
Efficacy and Safety of Technetium Tc 99m Sulfur Colloid Injection for Tracing Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial
NCT07764653CI-TRIAL-00122053completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is a prospective multicentre phase-3 study that aims to evaluate the detection rate of sentinel lymph node in patients with breast cancer. To compare the detection rates of Technetium Tc 99m Sulfur Colloid Injection(99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracing(MHI) for lymphatic tracing in patients with breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Nodes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone Hydrochloride Injection for Tracing | Drug | — | UNRESOLVED |
| Technetium Tc 99m Sulfur Colloid Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: 99mTc-SC and MHI Intra-individual Control Group
- description
- All enrolled patients will receive both Technetium \[99mTc\] Sulfur Colloid Injection (99mTc-SC) and Mitoxantrone Hydrochloride Injection for Tracer (MHI) as intra-individual controls prior to sentinel lymph node biopsy (SLNB). 1. 99mTc-SC Administration: Administered subcutaneously (peritumoral or subareolar) 3 to 18 hours prior to surgery. The dosage is scheduled based on surgery timing: Same-day SLNB: 0.5 mCi 99mTc-SC injected 3 to 6 hours (±36 min) before SLNB. Next-day SLNB: 1.0 mCi 99mTc-SC injected 3 to 18 hours (±120 min) before SLNB. 2. MHI Administration: 0.5 to 2.0 mL (5.0 mg/mL) of MHI is injected subcutaneously (peritumoral or deep subcutaneous) approximately 15 minutes before SLNB, followed by local massage for 5 to 8 minutes. Sentinel lymph nodes (SLNs) will be localized and identified intraoperatively using a handheld gamma detector probe (hot spots) and visual inspection for blue staining.
- interventionNames
- Drug: Technetium Tc 99m Sulfur Colloid Injection
- Drug: Mitoxantrone Hydrochloride Injection for Tracing
Primary outcomes (1)
- measure
- Sentinel lymph node detection rate.
- timeFrame
- During surgery (Day 0 or Day 1))
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria 1. Able to understand and voluntarily sign a written informed consent. 2. Female subjects aged 18-70 years ( including 18 and 70 years ). 3. Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ； 4. Clinical stage 1 or 2； 5. For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan； 6. The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration. 7. Conventional preoperative examination showed no clear surgical contraindications Exclusion criteria 1)Participants are allergic to the test drug or its excipients or have a history of severe drug allergy ; 2)Participants with prior surgery for breast cancer or neoadjuvant chemotherapy ; 3)inflammatory breast cancer ; 4)Ipsilateral axillary clinical examination or imaging examination positive or puncture lymph node pathology positive, no breast cancer histopathological diagnosis or no puncture pathological examination ; 5)Have received any form of breast augmentation surgery ; 6)Participants with liver or kidney dysfunction, ALT, AST\>2.5 times ULN, Bilirubin \>1.5 times ULN, Serum creatinine \>1.5 times, or Investigators believe that liver and / or kidney damage to the extent that patients should not participate in this study;； 7)With serious or uncontrollable diseases : such as severe cardiovascular and cerebrovascular diseases ( blood disease, chronic congestive heart failure NYHA classification ≥ III level, etc. ), severe pulmonary insufficiency ( one second rate FEV1 / FVC \< 50 % or FEV1 \< 50 % predicted value or maximum ventilation volume per minute MVV \< 50L / min ), psychiatric patients ; 8)Participants with active infection of infectious diseases screening ( hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody ) ; 9)participated in clinical trials of other drugs within 3 months before screening; 10)) Patients with positive pregnancy test or pregnancy plan during lactation or screening period to 3 months after administration and unwilling to take effective contraceptive measures or egg donation plan; 11)Investigators considered that it was not suitable for the patients to participate in this trial
References
Publications (0)
Data not yet available
No reference posted for this study.